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Procedures used

Both the assessment teams commissioned and the council of experts take a GRADE approach in their work. GRADE stands for “Grading of Recommendations Assessment, Development and Evaluation” The methodology is the subject of ongoing development by an international working group (www.gradeworkinggroup.org) and is used by numerous organisations worldwide. An introduction was published in 2008 in a series of articles in the British Medical Journal. A comprehensive description is available in a series of articles published in 2011 – 2013 in the Journal of Clinical Epidemiology. (All these articles can be accessed at www.gradeworkinggroup.org [--> Publications].).

Since 2016, “GRADE Evidence to Decision/Recommendation” has been used in the drawing up of appraisal reports. The GRADE working group has developed a tool for this purpose (Guideline Development Tool, http://gradepro.org), which was originally designed for drawing up clinical guidelines. This is a practical web-based tool for organising and evaluating data gathered in health technology assessments (incl. appraisal). The four areas defined by the SMB of clinical effectiveness and safety, health economic analysis, legal aspects and ethical aspects are mapped in the “Evidence to Decision/Recommendation” procedure.

The Swiss Medical Board commissioned a Benefit Harm Assessment for the two last reports as a new innovative element of a Health Technology Assessment. Such a Benefit Harm Assessment is not always necessary. But it can support decision-making in complex decisions where benefits and side effects are close together or patient preferences play an important role. A decisive advantage of a Benefit Harm Assessment is that the data and assumptions used can be varied systematically and transparently and thus different opinions or also decision-making situations can be represented. Thus, Benefit Harm Assessment can represent a valuable bridge between the scientific assessment of the research question and the appraisal and formulation of recommendations by the interdisciplinary expert panel.